Video-Intervention to Inspire Treatment Adherence for Life for Adolescents

This a two-arm randomized controlled trial whose objective is to explore the impact of VITAL Start for Adolescents (VS4A), a video-based antiretroviral treatment (ART) adherence intervention, on a range of implementation and effectiveness outcomes. The study will be conducted in health facilities which provide HIV care to teens/adolescents in the Machinga and Balaka districts of Malawi with approximately 900 teens living with HIV and their treatment supporters (dyads). Dyads will be individually randomized on a 1:1 ratio to receive either the intervention or the standard of care. The VS4A intervention is designed to support Information, Motivation, and Behavioral skills (IMB) around adolescent ART adherence as well as strategies for enhancing treatment supporter social support. The intervention consists of: 1) a two-session video package with associated activities that both the adolescent and their treatment supporter will be asked to watch and participate in; 2) ART refill for the adolescent; 3) and intensive adherence counselling for those with a high viral load. The primary outcomes are adoption of the intervention and adolescent viral load suppression. The overall hypothesis is that VS4A will achieve high adoption and improve adolescent viral suppression.

NCT Number	NCT07064785
Lead Sponsor	Baylor College of Medicine Collaborators: University of North Carolina, Chapel Hill, National Institute on Minority Health and Health Disparities (NIMHD)
Conditions	HIV/AIDS
Enrollment	1,800 participants
Start Date	2025-07-25
Primary Completion	2026-09-30 (estimated)
Study Completion	2027-03-28 (estimated)
Updated on ClinicalTrials.gov	2026-04-20